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Signs and SymptomsAB-ULTRANCT06193096

Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners

A study testing Experimental product in people with Signs and Symptoms, run by AB Biotics, SA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized, prospective, double-blind, placebo-controlled study in ultramarathon runners to evaluate the effects of suplementation with i3.1 probiotic formulation on the relief of common digestive symptoms associated to intense physical exercise. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Signs and Symptoms
What is being tested?
Experimental product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
277 participants
Where
1 siteSpain
Study dates
15 Aug 2023to 10 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >18 years
  • Correctly registered in the Salomon Ultra Pirineu 100K® 2023 race
  • Stable medication planned during the study period
  • Willing to provide informed consent and follow study procedures
  • Have signed the consent provided by the organization of the Salomon Ultra Pirineu 100K® 2023 race

Who cannot join

  • Respiratory, gastrointestinal or systemic infection that has caused fever or fatigue in the 15 days prior to the study entry
  • Having taken probiotic-based supplements or dairy products with probiotics (including "Actimel" or yogurts with "bifidus") daily in the 15 days prior to the study start
  • Taking oral or parenteral antibiotics in the 15 days prior to the study start
  • History of gastrointestinal surgery within 6 months prior to the study start
  • History of cardiovascular event: angina, heart failure, myocardial infarction
  • Diabetes mellitus type 1 or 2
Show all 10Show fewer
  • Pregnancy or lactation, or women planning to conceive during the study period
  • Chronic gastrointestinal disease: inflammatory bowel disease (Crohn's disease, ulcerative colitis), pancreatitis, short bowel syndrome
  • Gastrointestinal disease or disorders: inflammatory bowel disease (ulcerative colitis, Crohn's disease), irritable bowel syndrome, chronic diarrhea or constipation
  • Diagnosis of severe kidney disease (chronic kidney failure) or liver disease (hepatitis, cholestasis, liver failure)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de Cerdanya

    Puigcerdà, Catalonia, 17520

Other trials in Spain

About this study

Official title: Evaluation of the Impact of a Probiotic-based Formula on Digestive Symptoms, General Symptoms and Mood in Ultra Runners

Randomized, prospective, double-blind, placebo-controlled study in ultramarathon runners to evaluate the effects of suplementation with i3.1 probiotic formulation on the relief of common digestive symptoms associated to intense physical exercise. Secondary study outcomes aim to evaluate the effect of the probiotic formulation on fatigue, discomfort and muscle pain, as well as anxiety and mood.

Read the detailed description

Gastrointestinal symptoms (GIS) are a common feature of intense exercise, especially in ultra-endurance events. The main objective of this study is to evaluate the impact of a 3-strain probiotic formulation comprising Lactiplantibacillus plantarum and Pediococcus acidilactici on digestive symptoms in a maximum of 300 runners registered in an organized ultra-marathon event. A randomized, prospective, double-blind, placebo-controlled study will be conducted. Once recruited, participants will be allocated to recieve either the probiotic or placebo (at a ratio 2:1) for 4 weeks prior to race day. During follow-up, study participants will fulfill several questionnaires at specific time points (baseline, week -3, -2, -1, -24 h previous to the race, as well as 24 h and 7 days after the race). This will be documented through a specifically designed, web-based platform. Digestive symptoms will be evaluated through validated questionnaires: modified from Pfeiffer et al (2012; main outcome) and the Gastrointestinal Symptoms Rating Scale (GSRS). Secondary objectives will comprise anxiety, mood, other symptoms (muscle pain, fatigue, respiratory symptoms), and performance in the ultra-marathon.

Being tested
Experimental product, Control product
Keywords
Gastrointestinal symptoms, exercise, probiotics
Medical subject headings
Signs and Symptoms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental productDietary supplement

    Probiotic mix (i3.1) comprising Pediococcus acidilactici KABPTM 021, Lactiplantibacillus plantarum KABPTM 022 and Lactiplantibacillus plantarum KABPTM 023 in a 1:1:1 ratio and with a total concentration of ≥3x10^9 total colony forming units (CFU) per sachet (stick). Other ingredients are dextrose and maltodextrin as excipients, aroma, flavorings and silicon dioxide. Experimental product will be taken over 4 weeks.

  • Control productDietary supplement

    Also called Placebo

    Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide.

    Control product will be taken over to weeks

Study groups in NCT06193096
Study groupRoleWhat they receive
Experimental groupExperimentalProbiotic formula, 1 stick/day
Receives: Dietary Supplement: Experimental product
Control groupPlacebo comparatorPlacebo formula, 1 stick/day
Receives: Dietary Supplement: Control product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Digestive symptoms associated to physical exercise

    Digestive tract digestive symptoms score measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

Secondary outcomes (18)

  1. Digestive symptoms - subscore general digestive discomfort

    Evaluation of general digestive discomfort measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

  2. Digestive symptoms - subscore upper gastrointestinal symptoms

    Evaluation of upper gastrointestinal symptoms subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

  3. Digestive symptoms - subscore lower gastrointestinal symptoms

    Evaluation of lower gastrointestinal symptoms subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

  4. Digestive symptoms - subscore other gastrointestinal symptoms

    Evaluation of other gastrointestinal symptoms (nausea, dizziness, stitch) subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

  5. Digestive symptoms - percentage of severity

    Percentage of participants with severe symptoms (value >4) measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms)

    Measured: Baseline, +24 hours after race

  6. Digestive symptoms measured with GSRS

    Evaluation of digestive symptoms measured with Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS has a 7-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms

    Measured: week -3, -2 and -1 previous race,-24 hours before race, +7 days after race

  7. Competitive Anxiety before race

    Score of the Competitive State Anxiety Inventory-2R (CSAI-2R) questionnaire. The scoring ranges from 0 (nothing) to 4 (a lot).

    Measured: -24 hours (before race)

  8. Race time

    Race time at the end of the ultra in participants who finalize the race

    Measured: +24 hours after the race

  9. Abandonment during the race

    Percentage of abandonment during the race for any reason (including gastrointestinal problems)

    Measured: +24 hours after the race

  10. Stool consistency

    Evaluation of stool consistency measured through Bristol scale (score from 1 to 7). Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea

    Measured: -24 hours before race, +24 hours after race

  11. Mood States

    Score of the total Profile of Mood States (POMS) and the associated factors: Tension, Depression, Anger, Vigor, and Fatigue, evaluated using a visual analogue scale (VAS). The scoring ranges from 0 (not at all) to 4 (extremely).

    Measured: +24 hours, +7 days (after race)

  12. Muscle pain

    Muscle pain, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely).

    Measured: -24 hours before race, +24 hours after race, +7 days

  13. Fatigue

    Fatigue, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely).

    Measured: -24 hours before race, +24 hours after race, +7 days

  14. Headache

    Headache, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely).

    Measured: -24 hours before race, +24 hours after race, +7 days

  15. Fever

    Number of fever episodes in a specified period of time

    Measured: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

  16. Respiratory symptoms

    Number of days with respiratory symptoms

    Measured: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

  17. Sleep quality

    Sleep quality, evaluated through 10-point scale. The scoring ranges from 0 (the worst quality) to 10 (best quality).

    Measured: Baseline, -24 hours before race, +7 days after race

  18. Adverse events

    Registration of adverse events throughout all study period

    Measured: Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start15 Aug 2023
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, prospective, double-blind, placebo-controlled
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06193096
Sponsor's protocol ID
AB-ULTRA
Acronym
AB-ULTRA
Status last verified
Jan 2024
First submitted
21 Dec 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cano-Contreras AD, Minero Alfaro IJ, Medina Lopez VM, Amieva Balmori M, Remes Troche JM, Espadaler Mazo J, Perez Lopez N. Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial. J Clin Gastroenterol. 2022 Feb 1;56(2):141-147. doi: 10.1097/MCG.0000000000001456.

    PubMed 33136781

  • de Oliveira EP, Burini RC, Jeukendrup A. Gastrointestinal complaints during exercise: prevalence, etiology, and nutritional recommendations. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S79-85. doi: 10.1007/s40279-014-0153-2.

    PubMed 24791919

  • Lorenzo-Zuniga V, Llop E, Suarez C, Alvarez B, Abreu L, Espadaler J, Serra J. I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. World J Gastroenterol. 2014 Jul 14;20(26):8709-16. doi: 10.3748/wjg.v20.i26.8709.

    PubMed 25024629

Questions about this trial

What is this clinical trial studying?

A study testing Experimental product in people with Signs and Symptoms, run by AB Biotics, SA at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digestive symptoms associated to physical exercise (time frame: Baseline, +24 hours after race). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06193096, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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